Skip to main content
Clinical Trials/NCT05836532
NCT05836532
Completed
N/A

Long Term Results of Surgical and Percutaneous Double Orefices Mitral Repair in Patient With p2 Prolapse Causing Degenerative Mitral Regurgitation

Michele De Bonis1 site in 1 country110 target enrollmentOctober 5, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Degenerative Mitral Valve Disease
Sponsor
Michele De Bonis
Enrollment
110
Locations
1
Primary Endpoint
MR 2+ or more recurrency
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Mitral regurgitation is a pathology affecting the left atrioventricular valve that causes a volumetric and pressure overload in the left chambers due to the loss of unidirectionality normally guaranteed by the cardiac valve system. The gold standard for severe mitral regurgitation is currently mitral valve plastic surgery.

Edge to edge, on the other hand, allows shorter CEC and aortic clamping times and does not require significant surgical experience in the field of mitral valve repair, therefore edge to edge could be an excellent strategy in patients suffering from mitral regurgitation caused by P2 prolapse when quadrangular resection cannot be performed.

The main objective of the present study is to examine the medium to long-term outcomes (in terms of survival and plastic outcomes) of patients undergoing central edge-to-edge to treat posterior flap pathology (P2).

Registry
clinicaltrials.gov
Start Date
October 5, 2019
End Date
October 15, 2019
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Michele De Bonis

Chief od Cardiac Surgery of Advanced and Research Therapies

Ospedale San Raffaele

Eligibility Criteria

Inclusion Criteria

  • Mitral regurgitation with degenerative etiology
  • Mitral pathology exclusively dependent on P2
  • Surgical creation of a double mitral valve orifice with or without a ring as the only mitral valve repair technique.

Exclusion Criteria

  • Other mitral regurgitation etiologies (eg. functional, radiation-induced, rheumatic...)

Outcomes

Primary Outcomes

MR 2+ or more recurrency

Time Frame: through study completion, a minimum of 2 years

Secondary Outcomes

  • Reintervention(through study completion, a minimum of 2 years)

Study Sites (1)

Loading locations...

Similar Trials